Drug accountability and the problems associated with it remain key issues for clinical trial management as we move into 2018.
Using an IRT (IVR/IWR) system to manage the distribution and assignment of investigational product (IP) is now a well established practice. Most IRTs these days also include some method of +

The ability to track the temperature excursions of an investigational product has taken on an increasing importance in clinical trials. Temp tales and similar devices are used to record the drug’s environmental exposure from the time it is sealed into a shipping container at the warehouse to the time it +

When selecting an IRT (IVR/IWR) system for your clinical trial, what features should it have to ensure you can adequately manage the critical but logistically complicated world of study drug?
Here’s a quick checklist of things to consider:
Ability to have ‘at-a-glance’ access to information relevant to study drug– for example, in +

The Challenge:
Industry statistics indicate that 50% of the sites initiated for a clinical trial enroll 0-1 subjects; with 25% enrolling none at all. With numbers like these, decisions on where and how to distribute precious and expensive study drug become a serious matter for senior management and project teams. +

Required Non-Investigational Materials
It doesn’t seem like a big deal until you have to do it – managing the bandages, syringes, saline solution, tubing, and so on, that Sites may require during the conduct of your clinical trial. The non-investigational materials required for use at clinic visits are often regarded as +

Conducting a clinical trial – even a small one – is expensive. Pressure to contain costs is a constant presence in the lives of procurement managers, project managers, and senior personnel in all operational areas of Sponsor-companies and CROs. Accordingly, vendors who serve the pharmaceutical industry also live under intense +

Challenge:
The cost of producing an adequate store of investigational drug for a clinical trial remains high – significant enough that new ways to forecast manufacturing quantities, predict optimal shipping schedules, and differentially assign drug to sites based on enrollment estimates are constantly being developed.
How might IRT systems provide additional methods +

Problem: A classic struggle in the world of clinical trials is how to ensure there is ‘just enough’ drug at each study site throughout the trial – that is, how to achieve minimal wasting of precious investigational product, but minimize, at the same time, the risk that a site +

Yikes, someone left the package out in the heat!
Problem:
Your drug must remain within a set temperature range at all times. How are you going to ensure drug that experiences a temperature deviation is not distributed to subjects?
Your packaging and transport vendor(s) will record temperature deviations that occur between the manufacturer +

Help, the delivery van ran over the study drug …!
Problem:
Despite the best laid plans, whatever can happen, does happen when a clinical trial is in the field. Examples:
Kit 690, the study drug unit about to be assigned to Subject A, was damaged in transit and can’t +

Problem:
Your study's protocol calls for the return of unused study drug to the clinical site at each visit, when new drug is distributed. This drug accountability needs to be documented not merely at the container level, which is the only way your current IRT allows, but at the capsule +

Houston, we have a problem…
These are the words no one wants to hear! Your clinical supplies vendor has called to tell you there is a problem with one of your drug batches. You need to locate and recall all kits in the batch for destruction.
- Where are the kits with +